openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 14
Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
device · product 2 of 14
Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
device · product 3 of 14
Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
device · product 4 of 14
Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
device · product 5 of 14
Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
device · product 6 of 14
Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
device · product 7 of 14
Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
device · product 8 of 14
Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
device · product 9 of 14
Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
device · product 10 of 14
Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
device · product 11 of 14
Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
device · product 12 of 14
Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
device · product 13 of 14
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
device · product 14 of 14
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Code information
Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
Distribution pattern
Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
